User Protocol for Evaluation of Qualitative Test P

EP12-A2Vol.28No.3ReplacesEP12-AVol.22No.14UserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuideline—SecondEditionThisdocumentprovidesaconsistentapproachforprotocoldesignanddataanalysiswhenevaluatingqualitativediagnostictests.Guidanceisprovidedforbothprecisionandmethod-comparisonstudies.AguidelineforglobalapplicationdevelopedthroughtheClinicalandLaboratoryStandardsInstituteconsensusprocess.EP12-A2ISBN1-56238-654-9Volume28Number3ISSN0273-3099UserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuideline—SecondEditionPatriciaE.Garrett,PhDFredD.Lasky,PhDKristenL.Meier,PhDAbstractClinicalandLaboratoryStandardsInstitutedocumentEP12-A2—UserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuideline—SecondEditionprovidestheuserwithaconsistentapproachforprotocoldesignanddataanalysiswhenevaluatingqualitativediagnostictests.Guidanceisprovidedforbothprecisionandmethod-comparisonstudies.ClinicalandLaboratoryStandardsInstitute(CLSI).UserProtocolforEvaluationofQualitativeTestPerformance;ApprovedGuideline—SecondEdition.CLSIdocumentEP12-A2(ISBN1-56238-654-9).ClinicalandLaboratoryStandardsInstitute,940WestValleyRoad,Suite1400,Wayne,Pennsylvania19087-1898USA,2008.(FormerlyNCCLS)TheClinicalandLaboratoryStandardsInstituteconsensusprocess,whichisthemechanismformovingadocumentthroughtwoormorelevelsofreviewbythehealthcarecommunity,isanongoingprocess.Usersshouldexpectrevisededitionsofanygivendocument.Becauserapidchangesintechnologymayaffecttheprocedures,methods,andprotocolsinastandardorguideline,usersshouldreplaceoutdatededitionswiththecurrenteditionsofCLSI/NCCLSdocuments.CurrenteditionsarelistedintheCLSIcatalogandpostedonourwebsiteat:Telephone:[phone];Fax:[phone];E-Mail:[e-mail];Website: CommitteeMembership........................................................................................................................iii Foreword..............................................................................................................................................vii LaboratoryErrorSourcesandCLSIEvaluationProtocolsDocuments.................................................ix 1 Scope..........................................................................................................................................1 2 Introduction................................................................................................................................1 3 StandardPrecautions..................................................................................................................2 4 ClinicalUtility...........................................................................................................................2 4.1 ScreeningTests.............................................................................................................3 4.2 DiagnosticTests............................................................................................................3 4.3 ConfirmatoryTests.......................................................................................................3 5 Terminology...............................................................................................................................3 5.1 ANoteonTerminology................................................................................................3 5.2 TermsforComparativeBenchmark..............................................................................4 5.3 Definitions....................................................................................................................5 6 DeviceFamiliarizationandTraining.........................................................................................8 6.1 Purpose.........................................................................................................................8 6.2 Duration........................................................................................................................8 7 EvaluationMaterials..................................................................................................................8 7.1 Controls.........................................................................................................................8 7.2 SpecimenCollectionandHandling..............................................................................8 8 BiasandImprecisionStudies.....................................................................................................8 8.1 AnalyteConcentrationsNeartheCutoff.......................................................................9 8.2 NegativeandPositiveControls................................